s0423 pemetrexed disodium in treating patients with recurrent and unresectable or metastatic chondrosarcoma

Conditions: Sarcoma

Summary: rationale: pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. purpose: this phase ii trial is studying how well pemetrexed disodium works in treating patients with recurrent and unresectable or metastatic chondrosarcoma.

objectives: primary * determine the response rate (confirmed and unconfirmed complete response and partial response) in patients with recurrent and unresectable or metastatic chondrosarcoma treated with pemetrexed disodium. secondary * determine the toxicity of this drug in these patients. * correlate, preliminarily, response rates with deletions of methylthioadenosine phosphorylase (mtap), as analyzed by fluorescence in-situ hybridization (fish), in patients treated with this drug. outline: this is a multicenter study. patients are stratified according to prior chemotherapy (yes vs no). patients receive pemetrexed disodium iv over 10 minutes on day 1. courses repeat every 21 days\* in the absence of disease progression or unacceptable toxicity. beginning 7 days before the first dose of pemetrexed disodium and continuing until 21 days after the completion of pemetrexed disodium, patients receive cyanocobalamin (vitamin b_12) intramuscularly once every 63 days and oral folic acid once daily. note: \*the duration of course 1 is 28 days; the duration of all subsequent courses is 21 days. patients achieving a complete response (cr) receive 2 additional courses beyond cr. patients achieving a confirmed partial response (pr) that is resectable, proceed to surgical resection and then receive 2 additional courses of therapy after recovering from surgery. patients achieving a confirmed pr that is not resectable continue treatment in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 5 years. projected accrual: a total of 40-75 patients (20-40 in the previously treated stratum and 20-35 in the previously untreated stratum) will be accrued for this study within 20-37.5 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed chondrosarcoma * histologic grade g2 or g3 * recurrent and unresectable or metastatic disease * measurable disease by x-ray, scan, ultrasound, or physical examination * no known cns metastases patient characteristics: age * 18 and over performance status * zubrod 0-2 life expectancy * not specified hematopoietic * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 hepatic * bilirubin \< 1.5 times upper limit of normal (uln) * sgot or sgpt \< 2.5 times uln (5 times uln if liver metastases are present) renal * creatinine clearance \> 45 ml/min other * not pregnant or nursing * fertile patients must use effective contraception * able to swallow oral medication * no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage i or ii cancer in complete remission prior concurrent therapy: biologic therapy * more than 28 days since prior biologic therapy for this malignancy chemotherapy * more than 28 days since prior chemotherapy for this malignancy endocrine therapy * not specified radiotherapy * at least 60 days since prior radiotherapy to the target lesion\* * no concurrent radiotherapy note: \*target lesion must have demonstrated disease progression after completion of therapy surgery * at least 21 days since prior surgery and recovered other * more than 28 days since prior investigational drugs for this malignancy * at least 60 days since prior embolization or radiofrequency ablation to the target lesion\* * no more than 2 prior treatment regimens for this malignancy * no concurrent antiretroviral therapy for hiv-positive patients note: \*target lesion must have demonstrated disease progression after completion of therapy

Keywords: chondrosarcoma